Mass Balance Study of [14C]-Orvepitant Oral Solution in Healthy Male Subjects

A Single Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C] Orvepitant in Healthy Male Subjects After Oral Dosing

This is a single centre, open-label, non-randomised study to assess the mass balance recovery, absorption, metabolism, and excretion of a single oral dose of [14C]-orvepitant in healthy male subjects. It is planned to enrol 6 subjects. Each subject will receive a single dose of 30 mg [14C] orvepitant containing not more than (NMT) 3.7 megabecquerel (MBq) [14C], administered as an oral solution in the fasted state. Subjects will be admitted in the evening on the day prior to [14C]-orvepitant administration and will be dosed in the morning following an overnight fast. It is planned that subjects will remain resident in the clinical unit until 168 hours post-dose (Day 8) when they will be discharged from the clinical unit. Through the resident period samples (blood, urine, faeces) will be collected and analysed for mass balance, total radioactivity, orvepitant levels. Metabolite profiling and ID will also be performed.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [14C]-orvepitant

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Key Inclusion Criteria:

• Healthy males
• Aged 30 to 65 years inclusive at the time of signing informed consent.
• Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening.
• Must provide written informed consent.
• Must agree to adhere to the contraception requirements

Key Exclusion Criteria:

• History of any drug or alcohol abuse in the past 2 years.
• Regular alcohol consumption >21 units per week.
• Current smokers and those who have smoked within the last 12 months.
• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
• Clinically significant abnormal clinical chemistry, haematology, or urinalysis as judged by the Investigator.
• Subjects with a presence of any of the following at screening: bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) >1.5 × the upper limit of normal.
• Confirmed positive drugs of abuse test result.
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
• Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min using the Cockcroft-Gault equation.
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, or GI disease, neurological or psychiatric disorder, as judged by the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-orvepitant; [14C]-orvepitant administered as 30mg single dose in oral solution	Drug: [14C]-orvepitant; Oral solution of [14C]-orvepitant; Other Names: orvepitant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of radioactive dose recovered in urine and faeces and total percentage	168 hours
Concentration of total radioactivity in blood and plasma	168 hours

Collaborators and Investigators

• Sponsor: Nerre Therapeutics Ltd.
• Investigators: Principal Investigator: Principal Investigator, Quotient Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): June 28, 2020
• Study Completion (Actual): June 28, 2020

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 10, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ORV-1-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No